Lobaplatin for injection

1. Pharmacology: It has alkylating effect and belongs to alkylating agent (in a broad sense). This product has clear cytotoxic effect on various animal and human tumor cell lines, which is similar to or stronger than the anti-tumor effect of cisplatin. It still has certain cytotoxic effect on cell lines resistant to cisplatin. 2. Toxicology: Long-term toxicity tests on rats and dogs show that its toxicity is similar to that of carboplatin, and the main toxicity is bone marrow hematopoiesis inhibition. 3. Low renal toxicity, both in vivo and in vitro tests show mutagenic effect, and no carcinogenic test has been conducted, but this type of alkylating agent has potential teratogenic and carcinogenic effects.

The main ingredient of this product is lobaplatin. Chemical name: 1,2-diaminomethyl-cyclobutane-lactic acid platinum. Chemical structure: Molecular formula: C9H18N2O3Pt Molecular weight: 397.34

This product is white freeze-dried powder.

Treatment of inoperable metastatic breast cancer; treatment of inoperable transformed small cell lung cancer; treatment of chronic myeloid leukemia

Dissolve with 5 ml of water for injection before use. This solution should be used within 4 hours (storage temperature 2-8°C). Intravenous injection is 50 mg/m2 per body surface area. When used again, wait until the blood toxicity or other clinical side effects are completely recovered. The recommended interval between applications is 3 weeks. If the side effects recover slowly, the interval between applications can be extended. Duration of medication: The duration of treatment should be based on the response of the tumor. At least 2 courses of treatment should be used. If the tumor begins to shrink, treatment can be continued, with a total of up to 6 courses.

1. Hematologic toxicity: Among the dose-limiting toxicities of lobaplatin, thrombocytopenia is the most severe. About 26.9% of patients with solid tumors have platelet counts below 50,000/mm3. In patients with ovarian cancer who have received high-dose chemotherapy, the frequency of thrombocytopenia is as high as 75%. Thrombocytopenia often begins 2 weeks (14 days) after injection of lobaplatin, and the platelet count often returns to 100,000/mm3 1 week after the decline. In 15% of patients (up to 32.5% in patients with ovarian cancer after massive chemotherapy), the white blood cell count is as low as 2000/mm3. Hemogram changes are reversible, but can cause secondary side effects, such as bleeding caused by thrombocytopenia and infection caused by leukopenia. 2. Gastrointestinal toxicity: 34.3% of patients experienced vomiting, but only 6.7% of patients were more severe; 14.8% of patients experienced nausea, and it is recommended to use preventive antiemetics; 3.5% of patients experienced diarrhea. 3. Neurotoxicity: 1.3% of patients experience paresthesia, neurological disease, neuralgia, ototoxicity, mental confusion and visual abnormalities, etc., which only occur in less than 0.5% of patients. 4. Renal toxicity: When using lobaplatin, most patients do not need a large amount of infusion or/and forced diuresis, and renal dysfunction is rare. Insufficient fluid intake and severe vomiting after the use of lobaplatin in patients with anorexia can cause toxic renal failure. 5. Hepatotoxicity: After the use of lobaplatin, there is occasionally a mild reversible increase in SAST and SALT. This increase can also be caused by liver metastasis, but the causal relationship with lobaplatin cannot be excluded. 6. Electrolyte changes: Electrolyte changes are not a side effect of lobaplatin. 7. Allergic reactions: About 1.9% of patients experience allergic reactions (such as rash-like purple palace, skin flushing, skin reactions). These side effects often occur in ovarian cancer patients who have been treated with large amounts of platinum compounds in the past. In chronic myeloid leukemia, there is no such side effect. 8. Other side effects: There is no long-term carcinogenicity test for lobaplatin. Compounds with the same mechanism as lobaplatin have teratogenic and carcinogenic effects. Therefore, the risk of secondary tumors cannot be ruled out during lobaplatin treatment. The side effects of lobaplatin on male fertility cannot be completely ruled out.

Patients with bone marrow suppression, coagulation disorders (which may increase the risk of bleeding or bleeding) and renal impairment are contraindicated. Patients with allergic reactions to platinum compounds are contraindicated.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: Contraindicated during pregnancy and lactation. Women of childbearing potential should avoid pregnancy during lobaplatin treatment and within 6 months after lobaplatin treatment is terminated. Precautions for the elderly: Not yet clear.

If lobaplatin and other bone marrow suppressive drugs are used simultaneously, bone marrow toxicity may be increased.

Keep in a dark place and tightly closed at 25℃.

50mg (anhydrous)

36 months

Hainan Changan International Pharmaceutical Co., Ltd.

• Founded in:

  1993-08-19

• Address:

  Haikou National High-tech Industrial Development Zone

• Tax NO.:

  91460000708857819G

• Registered Funds:

  81.63 million yuan

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